MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.406

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); Irritation (1941); Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that a revision surgery occurred due to a non-union.On (b)(6) 2013, the patient was implanted with a condylar plate, one 5.0mm cortical screw, one 4.5mm cortex screw, and six 5.0mm variable angle locking screws in the distal femur.Later, x-rays indicated that the plate was bent.All of the hardware was explanted on (b)(6) 2014 and revised to an older distal femur plate.It was reported that the plate was bent at the junction of the shaft and base, but did not seem to encounter a screw hole.It was reported that there was a nonunion and the patient experienced pain, irritation and discomfort.No other issues were reported with the explanted devices.No patient harm or surgical delay was reported.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product codes: hrs, hwc.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history review was conducted.The report indicates that there no ncrs were generated during production.There were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4129488
• MDR Text Key: 4944023
• Report Number: 1000562954-2014-10186
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.406
• Device Lot Number: 8110595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84